NCT01930903Unknown不适用
Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF) at 12 months.
研究概览
简要总结
The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided a written informed consent
- •Subject >/= 18 years.
- •Patient affiliated to social security
- •Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
- •Subject eligible for percutaneous coronary intervention AND undergoing a chronical oral anticoagulant treatment OR undergoing any semi-urgent invasive or non cardiac surgical planned intervention with major bleeding risks
- •Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
- •De Novo coronary lesions: >/= 50% - <100%
- •Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
- •Target lesion length </= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
- •Reference diameters targeted vessels >/=2.5mm and </= 4.0 mm (visual estimation or QCA)
排除标准
- •Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
- •Subject with a life expectancy less than 1 year
- •Vulnerable subject, protected by law, unable to give his/her consent
- •Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
- •Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
- •Subject under chronical oral anti-coagulant treatment (optionnal indication)
- •Subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (DAPT) for at least 3 weeks
- •In stent restenotic lesion
- •Target lesion on vessels with nominal diameter < 2.5 mm
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •Chronical Total occlusion (CTO)
- •Angioplasty indication for STEMI
- •Patient with signs of cardiogenic shock
- •Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
- •"Staged procedure" > 8 days after the initial angioplasty
- •Documented left ventricular ejection fraction (LVEF) </= 30%
- •Target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc...)
- •Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.
结局指标
主要结局
Target Lesion Failure (TLF) at 12 months.
时间窗: 12 months
TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), urgent coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).
次要结局
- Bleeding rate according to BARC definition(1, 6 and 12 months)
- MACCE(1, 6 and 12 months)
- Myocardial Infarction (MI) (Q wave and non Q wave)(1, 6 and 12 months)
- Target Lesion Failure(1 and 6 months)
- Definite incidence of stent thrombosis(1, 6 and 12 months)
- Target lesion failure for kidney failure patients (clearance < 30 ml/ min)(1, 6 and 12 months)
- Clinically driven target lesion revascularization(1, 6 and 12 months)
- Target lesion failure for patients >/= 80 years(1, 6 and 12 months)
- Bleeding rate according to BARC definition for patients >/= 80 years(1, 6 and 12 months)
- Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)(1, 6 and 12 months)
- Clinically driven target vessel revascularization(1, 6 and 12 months)
- All deaths(1, 6 and 12 months)
研究者
研究点 (1)
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